Arthrex® AR-7300RBERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867041967), received between Jul 26, 2016 and Jan 6, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7300RBE ROUND BURR ADVANCED AND LOCKED DURING USE. THIS WAS DISCOVERED DURING A WRIST ARTHROSCOPY/RHIZARTHROSIS PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER SHAVER BLADE. ADDITIONAL INFORMATION PROVIDED 22-DEC-2025: IT WAS FURTHER REPORTED THAT NO BREAKAGE OR PRODUCTION OF DEBRIS OCCURRED. NO CASE DELAY WAS EXPERIENCED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973497 ↗
• MalfunctionJan 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HAND SURGERY THE DEVICE JAMMED DURING RESECTION IN THE PATIENT. THE DEVICE COULD NOT BE USED AFTERWARDS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158365 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE TIP BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831202 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED ON 06/09/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-7300RBE BURRS INTERNAL SHAFT BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558474 ↗
• MalfunctionMar 14, 2024Material Fragmentation; Material Fragmentation

  ON 02/29/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-7300RBE BURR WAS CAUSING DEBRIS AS SOON AS IT MADE CONTACT WITH BONE. BROKEN PIECES FULLY RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902989 ↗
• MalfunctionJan 16, 2024Break; Break

  ON 12/19/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) THAT AN AR-7300RBE BURR BLADE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519432 ↗
• MalfunctionSep 21, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7300RBE SMALL JOINT ROUND BURR BROKE, NO LOAD WAS APPLIED. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON "(B)(6) 2031". THE CASE WAS COMPLETED USING A NEW AR-7300RBE.

  Patient problems: Insufficient Information

  MAUDE report 12507255 ↗
• InjuryDec 12, 2018Entrapment of Device; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SHAVER BLADE WAS SPREADING METAL PIECES IN THE PATIENT'S JOINT. ACCORDING TO THE SURGEON TWO METAL PIECES WERE GRINDING AGAINST EACH OTHER AND METAL PIECES SPREAD ALL OVER THE JOINT. IT EXTENDED THE SURGERY TIME BECAUSE THE SURGEONS HAD TO SPEND TIME GETTING ALL THE PIECES OUT OF THE JOINT. THE SURGEON CAN'T CONFIRM THAT ALL THE PIECES ARE RETRIEVED. A DIFFERENT SHAVER BLADE (PART NUMBER UNKNOWN) WAS USED TO FINISH THE SURGERY SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 23 NOV 2018: THE SURGERY TOOK 1 HOUR LONGER THAN "INITIALY" PLANNED. WE REQUESTED FURTHER INFORMATION IF ALL THE FRAGMENTS ARE RETRIEVED BUT WE DID NOT GET A 100% CONFIRMATION OF THIS. STATEMENT OF THE SALES REP (ARTHREX DK): THE SURGEON WAS ABLE TO RETRIEVE THE METAL PIECES. I DO NOT HAVE AN X-RAY SO WE CANNOT BE 100% SURE THAT EVERYTHING WAS RETRIEVED. THE FACILITY DISCARDED THE DEVICE BUT WILL SEND IN A UNUSED DEVICE OF THE SAME BATCH FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8155440 ↗
• InjuryJul 26, 2016Sticking

  IT WAS REPORTED THAT DURING A BILATERAL ELBOW ARTHROSCOPY, THE SHAVER BLADE STOPPED ROTATING. SURGERY WAS FINISHED SUCCESSFULLY BUT SURGEON HAD TO USE A MANUAL BURR AND ARTHROSCOPY FORCEPS TO FINISH THE SUBTOTAL CORONOIDECTOMY. DUE TO THE SWITCH OF THE SURGICAL TECHNIQUE, OPERATION TOOK CONSIDERABLY LONGER THAN USING THE SHAVER. ANESTHESIA OF THE PATIENT WAS STABLE AND PROLONGED USE DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 5823523 ↗